Armed with a 102-page report, and a full-time staff, the New York State Task Force on Life & The Law, part of the New York State Department of Health, is launching an all-out campaign to warn consumers of the potential side effects posed by dietary supplements. [www.health.state.ny.us/nysdoh/taskfce/ ]

The Task Force is composed of physicians and lawyers, who can nary find the log in their own eye before searching for the speck in another’s. With over 100,000 preventable deaths annually from properly prescribed drugs administered in hospitals, these physicians and lawyers have set out to protect New York consumers from alleged side effects posed by innocent traditional remedies like kava kava.

Claiming the Federal Food & Drug Administration has failed to take action to protect the public from potentially harmful dietary supplements, New York health authorities are taking matters into their own hands.

Adverse event reporting

With no demonstration project to prove that new requirements and laws will prevent morbidity or mortality, the Task Force will require all dietary supplement manufacturers to record serious adverse events associated with their products. But what if such a measure only ends up costing consumers more money and results in no benefits to the public?

Most complaints of side effects received by dietary supplement companies are transient and reversible, and non-life threatening, like constipation from taking too much calcium, loose stool from too much magnesium, cramping and nausea from iron pills, flushing from excessive niacin, or finger tingling from too much vitamin B6. The adverse event monitors may end up being nothing more than constipation counters.

The Task Force is averse to “self medicating” and claims use of dietary supplements may delay needed care by a physician. So, what are over-the-counter drugs? The Task Force’s efforts could be legally challenged as selectively restricting trade. Why are dietary supplements being singled out for scrutiny when Vioxx, Celebrex and Bextra produce more serious side effects and have killed thousands of Americans? Instead of reigning in on the pharmaceutical industry, the Task Force has chosen to regulate dietary supplements, and intends to require supplement companies to pay fees to cover for enforcement of regulations.

Safety Testing

The Task Force mistakenly claims that the FDA does not require dietary supplement companies to submit safety data to the FDA before products are sold to consumers. The 1994 Dietary Supplement Health and Education Act requires any new dietary ingredient to undergo safety testing. Enforcement of this requirement has been lax at the federal level, possibly because the FDA wants to lure unsafe products onto the market so it will have a stronger mandate to regulate.

Safety in question: kava

The Task Force wants to alert consumers that particular products have not been determined to be safe or efficacious. One such supplement the Task Force has identified is kava kava, where reports emanating from Europe claimed this herb caused liver toxicity. But the warning issued by the U.S. FDA, which alleged liver problems associated with kava, was premature and unfounded. German health authorities indicate, “When assessed primarily by the British regulatory authority and also by us, a critical analysis of the suspected cases (n = 19) in Germany reveals that only in 1 single patient a very probable causal relationship could be established between kava treatment and the development of toxic liver disease.” [Phytomedicine 10(5):440-6, 2003] Nonetheless, the New York Task Force is already pre-committed to warning the public over the alleged side effects posed by kava.

Meanwhile, the Task Force does nothing to alert the public that the drugs their very own Task Members prescribe, such as acetaminophen (Tylenol) cause far more liver toxicity (70,000 cases annually, many liver transplants and a few hundred deaths) than kava (19 ill-founded reports).

While dietary supplements are safer than aspirin, vaccines, and even table salt, the Task Force has decided to ensure that New York consumers are aware of risks “reasonably expected” from use of these products. Imagine, this asserts dietary supplement companies are knowingly selling unsafe products which would put them at risk for lawsuits that could put them out of business. Does this sound true?

Ephedra and plant estrogens are singled out

The Task Force report features a section listing the side effects posed by products containing ephedra, particularly mortal heart attacks experienced by a few users who may have intentionally overdosed on these products in rushed attempts to lose weight. Weight loss clinics now prescribe anti-obesity drugs that have some of the same side effects as ephedra. Strongly caffeinated beverages are known to cause the same type of heart beat irregularities posed by ephedra. Will the Task Force ban Turkish coffee?

Another class of supplements that Task Force deems to be unsafe are plant estrogens, about 1/000th the strength of natural estrogen. Even though some of the same doctors on the Task Force prescribed estrogen replacement for women for years without scientific evidence of its safety and effectiveness, they have chosen to castigate phytoestrogen supplements. But what of soy milk, burgers, cereal, tofu, miso, flax, rye, all which are rich in phytoestrogens?

Mega dosing

The Task Force report warns of “mega dosing,” which can result in toxic liver from vitamin A supplements. However, only about 30 cases of liver toxicity associated with vitamin A supplements are reported annually and most of these are among patients with pre-existing liver disease, alcoholics, etc. The Task Force claims excessive vitamin D may cause calcium overload, but recent studies disprove this notion.

Drug-supplement interactions

The Task Force report expresses concern over concurrent use of medications and supplements. There are many herb-drug and drug-drug interactions, too many to count. Nothing is said of drugs interfering with other drugs, only herbs that interfere with drugs.

The Task Force considers dietary supplements to be problematic if they interfere with prescription drugs when vitamin, mineral and amino acid supplements are essential for life, the drugs are not. It is the drugs that interfere with the nutrients.

The Task Force report lists the potential side effects posed by specific dietary supplements, but never mentions that most prescription drugs deplete the body of essential nutrients, ensuring patients never get well. Examples are aspirin which depletes vitamin C and folic acid, steroids which deplete minerals and vitamin C, diuretics which deplete minerals and vitamin B1 which can result in heart failure, statin drugs that deplete coenzyme Q10, heartburn remedies that deplete vitamin B12, to name a few. None of these drugs disclose these facts to consumers on product labels.

Smear campaign

The Task Force urges the Department of Health to undertake a “broad public education campaign” concerning dietary supplements, captained by physicians who are poorly trained in the topic.

The Task Force report has been two years in planning, so there is no excuse for its errors and misdirection. The report embarrassingly reveals the widespread lack of education by health authorities concerning dietary supplements. The fact that the biological action of most prescription drugs can be duplicated with safer and less expensive dietary supplements is not revealed to the public.

If dietary supplement manufacturers have any gumption, they should file a restraint of trade lawsuit against the Task Force the moment it is put into force.

Bill Sardi, President
Knowledge of Health, Inc.
San Dimas, California

To send a comment to the Task Force:
New York State Department of Health
Corning Tower
Empire State Plaza,
Albany, NY 12237

Journal American Medical Assn April 15, 1998, Volume 279, pp 1200-05

Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies.

Lazarou J, Pomeranz BH, Corey PN
Department of Zoology, University of Toronto, Ontario, Canada.

OBJECTIVE: To estimate the incidence of serious and fatal adverse drug reactions (ADR) in hospital patients.

DATA SOURCES: Four electronic databases were searched from 1966 to 1996.

STUDY SELECTION: Of 153, we selected 39 prospective studies from U.S. hospitals.

DATA EXTRACTION: Data extracted independently by 2 investigators were analyzed by a random-effects model. To obtain the overall incidence of ADRs in hospitalized patients, we combined the incidence of ADRs occurring while in the hospital plus the incidence of ADRs causing admission to hospital. We excluded errors in drug administration, noncompliance, overdose, drug abuse, therapeutic failures, and possible ADRs. Serious ADRs were defined as those that required hospitalization, were permanently disabling, or resulted in death.

DATA SYNTHESIS: The overall incidence of serious ADRs was 6.7% and of fatal ADRs was 0.32% of hospitalized patients. We estimated that in 1994 overall 2216000 (1721000-2711000) hospitalized patients had serious ADRs and 106000 (76000-137000) had fatal ADRs, making these reactions between the fourth and sixth leading cause of death.

CONCLUSIONS: The incidence of serious and fatal ADRs in U.S. hospitals was found to be extremely high. While our results must be viewed with circumspection because of heterogeneity among studies and small biases in the samples, these data nevertheless suggest that ADRs represent an important clinical issue.